Medical devices and CE certification

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A medical device placed on the EU market must have a CE (“Conformité Européenne”) certification and comply with the EU Medical Devices Regulation (MDR; Regulation (EU) 2017/745) [1] or the EU In Vitro Diagnostic Medical Devices Regulation (IVDR; Regulation (EU) 2017/746) [2]. Read our overview on the process, plus find out how we can help.

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